ImmersiveTouch3 and MicrovisTouch— 510(k) K140860

Name: FDA 510(k) clearance K140860
Creator: U.S. Food and Drug Administration
Published: 2014-12-16

Substantially Equivalent

Immersivetouch

FDA 510(k) clearance K140860 for ImmersiveTouch3 and MicrovisTouch, Substantially Equivalent on 2014-12-16. Applicant: Immersivetouch. Device class: 2.

Clearance details

Applicant: Immersivetouch
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2014-04-03
Decision date: 2014-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Immersivetouch

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K230249 — Ikshana2023-10-16
K181813 — ImmersiveView Surgical Plan (IVSP®)2020-06-09

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K140860

K-number listed on FDA's recall record

Z-2041-2020 — ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment optionsClass III·Ongoing·Immersivetouch Inc·20200403

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140860.

Data sourced from openFDA. This site is unofficial and independent of the FDA.